Spine – Page 41 – Selby Spine

CARLSBAD, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch and completion of initial surgeries for its OsteoStrand™ Demineralized Bone Fibers. The first implantations were completed by Dr. Khalid Abbed, Vice Chair of Neuro Surgery and Director of Minimally Invasive Spine Surgery at Yale School of Medicine and orthopedic spine surgeon Michael W. Cluck, M.D., PhD, at the Bay Area Spine Care in San Jose, CA.

OsteoStrand fibers are the latest innovation in SeaSpine’s demineralized bone matrix (DBM) product family, which facilitate and aid in fusion. OsteoStrand fibers provide 100% demineralized bone fibers to maximize the osteoinductive content while providing a vastly improved conductive matrix. These fibers were developed through a disciplined R&D process that evaluated a variety of fiber geometries to deliver intraoperative handling and controlled expansion, to facilitate surgical placement, to maintain surgical position and to allow the fibers to better fill the surgical defect with the overriding goal to improve fusion potential.

“The handling properties of OsteoStrand Demineralized Bone Fibers are excellent; it is easily compressible and expands to fill the surgical defect upon implantation,” said Dr. Cluck. “The handling and 100% demineralized bone composition give me a high level of confidence for my fusion procedures.”

Dr. Khalid Abbed added, “The handling properties of OsteoStrand Demineralized Bone Fibers are excellent, and improved compared to other 100% DBM products that I have used in my practice. I believe this tissue product could lead to significant cost savings for my hospital and I look forward to evaluating the OsteoStrand Plus with Accell Bone Matrix.”

“OsteoStrand fibers will serve as a development platform for continued innovation in our orthobiologics portfolio and will further strengthen our top-three position in the U.S. DBM market while also providing operational leverage through our Irvine manufacturing facility,” said Keith Valentine, Chief Executive Officer and President of SeaSpine. “We plan to launch the OsteoStrand Plus Demineralized Bone Fibers with our proprietary Accell™ Bone Matrix on a limited basis in early 2018. We believe these product offerings deliver clinical value as payors and hospitals seek more cost effective orthobiologic solutions.”

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implant portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the potential benefits of the OsteoStrand Demineralized Bone Fibers product, including to improve fusion; the ability of the OsteoStrand Demineralized Bone Fibers to strengthen SeaSpine’s top-three position in the U.S. DBM market and provide operational leverage; the timing of launch of the OsteoStrand Plus Demineralized Bone Fibers product in early 2018; and the potential for new product offerings to clinical value to payors and hospitals. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

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Jennifer Kite-Powell , Contributor

As robotics in medicine becomes more widely adopted, two new studies look at the cost and advantages and disadvantages of robotic surgery versus freehand surgery.

University of Stanford researchers conducted a multiyear analysis and study with 24,000 patients with kidney cancer who needed laparoscopic surgery to remove a patient’s kidney indicated that the two approaches had comparable patient outcomes and hospital stays. Researchers analyzed data from 416 hospitals across the country from 2003 to 2015 for the study.

Robotic-assisted laparoscopic procedures have increased since 2015 and surpassed conventional laparoscopic procedures according to Dr. Benjamin Chung, Associate Professor of Urology at the University of Stanford. Dr. Chung said in a press release that although there was no statistical difference in outcome or length of hospital stay, the robotic-assisted surgeries cost more and had a higher probability of prolonged operative time. Over the 13-year period of Stanford study, robotic surgeries cost on average $2,700 more per patient.

Mazor Robotics, a publicly-traded Israeli company that makes robotic guidance systems for spine and brain surgeries, conducted a small controlled study on the use of robotic-guided spine surgery with 379 patients. These results and the remaining data from the study, collected by 10 surgeons from nine states indicated that relative risk for a complication was 5.3 times higher in fluoro-guided surgeries compared to the robotic guidance; and relative risk for revision surgery was 7.1 times higher for a fluoro-guided surgery compared to the robotic guided cases.

“We believe the study takes a significant step forward in shifting the conversation of whether robotics have a place in the spine operating room,” said Ori Hadomi, CEO, Mazor Robotics.

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BATON ROUGE, La., Nov. 1, 2017 /PRNewswire/ — Dr. Marco A. Rodriguez, M.D., a board-certified and fellowship-trained orthopedic spine surgeon has a least invasive philosophy when it comes to spine procedures and surgery. He launched the International Spine Institute in Baton Rouge, Louisiana to give patients an option for more effective treatment of a variety of degenerative spinal conditions, including herniated disc, sciatica, low back pain, spinal stenosis, neck pain, spondylolisthesis, and failed back surgery.

According to research in the Epidemiology of Spine Care: The Back Pain Dilemma, low back pain disorders are among the most frequently encountered problems in clinical medicine. Research shows that low back pain affects up to 80 percent of the population at some point in life. Another study, The Rising Prevalence of Chronic Low Back Pain, noted that low back pain is the second most common cause of disability for adults in the United States and a common reason for lost workdays. The study notes that the condition is also costly with total costs estimated to be between $100 to 200 billionannually, two-thirds of which are due to decreased wages and productivity.

Several treatment options have evolved in order to treat the low back pain, but all too often the least invasive procedure is not the one most tried and recommended. “Currently, patients suffering from low back facet related pain, who failed conservative treatment options, are treated by pain management doctors with facet injections or medial branch nerve blocks. If these injections achieve short-term relief, a percutaneous radiofrequency nerve ablation (RFA) procedure is usually performed. The RFA procedure achieves pain relief in about 75 percent of patients and it lasts about 12 months average,” says Dr. Rodriguez. The research is showing that while these procedures may show a short-term improvement in pain, the long-term benefits are not evident.

Spine surgery is another option and ranges from well-established approaches for lumbar discectomy and/or spinal canal decompression to spinal fusion. Although surgery and spinal fusion are effective for some select conditions, many patients forego these options due to fear of long painful recovery (2-6 months) and slow return to work. Those that are candidates for surgery often experience long painful recovery and lost productivity and wages. The Long-term Outcomes of Lumbar Fusion Among Workers’ Compensation Subjects: a historical cohort study, showed that two years after spinal fusion surgery only 26 percent of fusion cases had returned to work, while 67 percent who had tried nonsurgical procedures had gone back to work. The reoperation rate was 27 percent and 36 percent had complications. For lumbar fusion patients, the daily opioid use also increased 41 percent after surgery, with 76 percent of cases continuing opioid use after surgery.

Dr. Rodriguez has aimed to bridge the gap between pain management and spinal surgery with a philosophy of least invasive procedures. His goal is to provide a non-fusion option that gives people their lives back quickly and with as little pain and recovery as possible. Pain management is relevant and helpful in order to pinpoint the pain generator in the low back, and some of the facet joint injections and interventional procedures provide temporary relief for some patients. For many patients they don’t get long lasting relief. Often when patients fail pain management, they are referred to spinal surgeons. According to Dr. Rodriguez, there are too many spinal fusions done with poor outcomes and long recovery.

The study Long-Term Results of Endoscopic Dorsal Ramus Rhizotomy and Anatomic Variations of the Painful Lumbar Facet Joint, showed that “Endoscopic lumbar medial branch rhizotomy is safe, effective, and provides long-term benefit up to five years post-procedure. The endoscopic approach affords clinically superior longevity when compared to published results of radiofrequency ablation.”

At the International Spine Institute, Dr. Rodriguez focuses on endoscopic rhizotomy and discectomy surgery, which provide effective long-term relief from low back pain without the long recovery of spinal fusion. These procedures are done under conscious sedation or local anesthetic in an outpatient setting. This is done through a 1/2 inch incision for endoscopic. Patients experience minimal pain and discomfort and return to work and an active lifestyle as early as two weeks.

The endoscopic rhizotomy procedure alone has decreased the number of spinal fusions in Dr. Rodriguez’s practice significantly. He finds that most patients would rather have a least invasive, fusion sparing procedure than a spinal fusion or return to pain management every six to eight months for another RFA. His patient’s results have been astounding.

To learn more about Dr. Rodriguez and the International Spine Institute, visit ISpineI.com.

About International Spine Institute
The International Spine Institute, based in Baton Rouge, Louisiana, are leaders in less invasive spine procedures and surgery. Dr. Marco A. Rodriguez and his team strive to listen to patient’s needs and provide solutions that restore function, relieve pain, and help patients regain their quality of life. International Spine Institute’s motto is “Less Is So Much More.” For more information, visit ISpineI.com.

Related Images

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Dr. Marco A. Rodriguez of the International Spine Institute in Baton Rouge, Louisiana

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Endoscopic Rhizotomy

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Dr. Marco A. Rodriguez, MD International Spine Institute

SOURCE International Spine Institute

DUBLIN, November 1, 2017 /PRNewswire/ —

The “Global Spine Orthopaedic Devices Market: Drivers, Restraints, Opportunities; Trends and Opportunities to 2023”report has been added to Research and Markets’ offering.

The “Global Spine Orthopedic Devices Market” is Estimated to Witness a CAGR of 6.23% During 2017-2023

The market is dominated by the Spine Implants segment with the presence of advanced fusion and non-fusion procedures performed with orthobiologics and the availability of clinical data regarding the safety and efficacy of the devices. This enables surgeons to adopt devices for treatment of various spine-related disorders as these surgeries contribute 60% of the total orthopedic procedures.

Therefore, opportunities for growth in the emerging countries of LATAM and APAC remain vast. The increasing adoption of MI surgeries in treating orthopedic disorders, particularly in the elderly, and the growing availability of devices in the market also contribute to the growth of the market.

Europe accounted for the second largest market with chronic pain being one of the major complications with the rising burden of spine chronic cases (lower back). In 2015, the public spending on healthcare in Europe amounted to 18% of the overall government expenditure. The expenditure on chronic pain care with orthopedic devices is directly reimbursed to hospitals within the NHS. Clinical evidence of spine orthopedic devices compared to other treatments, such as drug therapy, are expected to increase during the forecast period.

Factors, such as high prevalence of orthopedic diseases, presence of large pool of patients, and rise in awareness about treatment for complex orthopedic disorders, drive the market growth in the emerging economies, especially APAC. Further, the increase in government spending in healthcare, infrastructure, research centers, and establishing of manufacturing facilities by major vendors in the market are influencing the high growth of the market.

Market Dynamics

Drivers

Rise in the prevalence of spinal disorders
Growing popularity of minimally invasive surgeries
Rise in elderly population
Increase in number of outpatient procedure

Opportunities

Adoption of spinal navigation technology
Increase usage of orthopedic biomaterials in spine surgery
Increase healthcare spending
Increase in mergers & acquisitions

Restraints

High cost of spine surgery procedures
Complications and risk associated with spine surgeries
Stringent regulatory framework and labeling requirement
Poor reimbursement policies
Intense competition among vendors

Key Topics Covered:

1 Industry Outlook

2 Report Outline

3 Market Snapshot

4 Market Outlook

5 Market Characteristics

6 Types: Market Size and Analysis

7 End User: Market Size and Analysis

8 Regions: Market Size and Analysis

9 Competitive Landscape

10 Vendor Profiles

11 Companies to Watch For

12 Other Prominent Vendors

Companies Mentioned

Alphatec Spine
Johnson & Johnson (DePuy Synthes, Inc)
K2M
Medtronic PLC
NuVasive, Inc.
OMNIlife Science
Orthofix International N.V.
SeaSpine Holdings Corp.
Stryker Corp.
Zimmer Biomet Holdings, Inc

For more information about this report visit https://www.researchandmarkets.com/research/6vvbbw/global_spine

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
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Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

Related Links

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DALLAS & THORNTON CLEVELEYS, UK (PRWEB) OCTOBER 31, 2017

Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions (Invibio).

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. Invibio’s PEEK-OPTIMA HA Enhanced polymer is an implantable biomaterial grade that combines two clinically proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA and Hydroxyapatite (HA), a well-known osteoconductive material. PEEK-OPTIMA HA Enhanced encourages bone on-growth on all surfaces of a device while providing the strength, versatility and performance advantages of its proven predecessor, PEEK-OPTIMA Natural.

“We are excited about the possibility of combining the proven clinical benefits of Invibio’s PEEK-OPTIMA HA Enhanced with the benefits of Pinnacle Spine’s patented InFill technology,” said Zach Sowell, President of Pinnacle Spine Group. “Once cleared we believe the combination of these two technologies will provide surgeons with an ideal solution for improved outcomes in lumbar fusion, one of the more challenging approaches to achieve successful fusion.”

“Pinnacle Spine Group and Invibio share a passion for trying to improve the effectiveness of bone growth in the graft space,” said John Devine Medical Business Director, Invibio Biomaterial Solutions. “The combination of Pinnacle’s technology with our own pioneering materials feels like an obvious collaboration.”

Invibio´s PEEK-OPTIMA HA Enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).

Pinnacle Spine Group was recently granted a new patent related to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies. In addition, Pinnacle was recently awarded a new patent related to the architecture of the lateral implant. These latest patents follow the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-510(k) cleared InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

About Invibio Biomaterial Solutions

Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. Further information is available on Invibio´s new website: https://invibio.com
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

Contact:
Mr. Zach Sowell, President
Pinnacle Spine Group, LLC
214-466-1428

Contacts
Invibio Biomaterial Solutions
Barbara Pasciak, Marketing Communications Manager
barbara.pasciak(at)invibio(dot)com, Phone +1 484-342-6041

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager
bsauer(at)victrex(dot)com, Phone +49 61 92 / 96 49 19

Victrex: Group media or Investor Relations enquiries
Andrew Hanson, Director of Investor Relations & Corporate Communications
ahanson(at)victrex(dot)com, Phone +44 12538 98121

November 1, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting instruments and surgery-ready procedural kits for the medical industry and surgeons worldwide, has launched the Cervical-One™ single-procedure instrument set for use in one and two-level cervical spine implant procedures. The novel instrument set is available for tailoring and branding by spine implant OEMs for securing both plates and screws and interbodies commonly used to treat spine degeneration and deformity cases.

ECA markets and sells its single-use instruments and complete procedural kits to medical device OEMs for private labeling and branding, saving them significant R&D investment and accelerating time to market for new product introduction or legacy product refresh. Tailored to implant manufacturer specifications the Cervical-One™ kits can be branded in different colors, handle shapes and sizes. The instrument sets are ready for rapid adoption across the marketplace to reduce operating cost, eliminate instrument cleaning and re-sterilization, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

“Cervical-One™ offers spine implant OEMs essentially an off-the-shelf and surgery ready solution that provides them differentiated instrumentation to both clinically and economically meet the growing demand for cervical spine degeneration repair,” said Lane Hale, president and CEO of ECA Medical Instruments. “The simplicity of design and modular instrument approach allows for easy branding and modification to meet surgeon needs for implant fixation, navigation, procedural stack up and OR efficiency gains,” he said.

ECA is marketing the fully disposable instrument kits in three configurations: 1) instrument set for anterior cervical plate and screw fixation, 2) interbody implant fixation kit, and 3) a combined anterior cervical discectomy fusion (ACDF) kit combining instrumentation.

The kits include the full complement of instruments needed by surgeons and OR teams including precision torque-limiters and drivers. All the instruments use state of the art medical grade polymers for strength and durability, are validated and packaged in sterile-pack fully recyclable trays.

An early adopter of the Cervical-One™ instrument kit is Zavation Medical, Jackson, MS. Zavation is collaborating with ECA to develop a family of kits for stand-alone and combined fixation of one and two-level plating and also interbody cages (artificial discs). Zavation expects to launch their new SteriCerv™ line of products in early 2018. Both Zavation and ECA demonstrated the new instrument kits to neurosurgeons and orthopaedic surgeons at the North American Spine Society (NASS) 2017 conference last week in Orlando.

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity spine surgeries in both the hospital and outpatient setting,” Hale said. “We’re excited to partner with both large and small/medium enterprise OEMs across the spine industry and bring these new instrument kits to market.”

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 35 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2017 by LivaNova. www.ecamedical.com

Media Contact: James Schultz

Phone: +1 805-990-6177

Email: jschultz@ecamedical.com

Jupiter, Florida., October 31, 2017 (PR NEWSWIRE) — Atlas Spine, Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Florida, today announced that the Ortus™ Expandable Posterior Lumbar Interbody System has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus™ PL is clearly differentiated from other expandable technology. For example it has one of the smallest starting heights (6.5mm) of any expandable device on the market, and relies on a unique, patented design that allows for implant expansion while restoring natural anatomic alignment in a single step. The device also features an open architecture that allows the surgeon to pack ample graft material after the device is deployed and expanded. This is the first implant in a comprehensive line of expandable interbody intellectual property that utilizes anterior, PLIF, oblique, and minimally invasive approaches and devices that the company plans on launching.

“Atlas has a deep pipeline of expandable technology and the Ortus™ 510(k) clearance presents a tremendous opportunity to establish our company as an expandable interbody technology market leader. The Ortus™ platform provides options and capabilities for surgeons focused on restoring spinal balance that is yet to be provided by other devices and companies. Paired with a minimally invasive surgical approach, Ortus™ PL is a powerful tool for spine surgeons seeking reliable fusions with minimal complexity and post-operative morbidity. Furthermore, the Ortus™ PL platform is well suited for anterior, posterior, lateral and oblique approaches, in addition to MIS,” notes Atlas Spine’s co-founder and CTO Matthew Baynham.

Atlas Spine’s CEO Douglass Watson adds, “We are thrilled to be in the expandable posterior lumbar interbody market. The response from key, opinion-leading surgeons is tremendous. We are preparing to launch the Ortus™ PL interbody device with our distributor network in the near future and look forward to numerous additional differentiated device clearances over the next several quarters.”

The U.S. FDA notified the company on the first day of the North Atlantic Spine Society (NASS) meeting. This is Atlas Spine, Inc’s 12^th product to receive 510(k) clearance by the U.S. FDA and allows the Company to access distribution channels and gain measurable market share. It also allows the company to focus on commercializing other significant projects in the pipeline.

About Atlas Spine, Inc.

Our mission is to create spinal implants and instrument systems that treat a variety of pathologies combining the highest level of performance with ease of use which translate to physician satisfaction and enhanced patient outcomes. The company has over 50 issued and pending patents and currently distributes a number of interbody and posterior stabilization systems and has also licensed technology to other companies in the spinal device market.

For more information about Atlas Spine, please visit atlasspine.com.

Contact: Matthew Miller, Atlas Spine Inc., (561) 741-1108 or mmiller@atlasspine.com. Atlas Spine Inc., 1555 Jupiter Park Drive, Suite 1; Jupiter, Florida 33458.

IRVINE, Calif., Oct. 25, 2017 /PRNewswire/ — Today, GS Solutions Inc., DBA GS Medical USA (GSM), a U.S. supplier of spinal implants and instrumentation and provider of high-quality surgical solutions, announced the full launch of the AnyPlus® Direct Lateral Interbody Fusion (DLIF) System after three months of an alpha launch period, and the Anterior and Posterior Disc Prep Sets.

Following strong sales growth of 32% in Q2 2017 versus the prior quarter, the GSM leadership team expects continued, positive growth for Q4 2017 and FY2018, supported by the launch of the aforementioned products.

“The company’s success thus far is in large part thanks to our strong relationship with surgeon partners and distributors, and we are thrilled to offer these new products in our portfolio of spinal solutions,” said James Shin, CEO. The company’s newest Direct Lateral System will be streamlined with unique features that offer many implant and instrument options to complement surgeon preferences.

“We understand the ever-evolving needs of our surgeon partners, and we continually strive to develop new and innovative implants and instrumentation, with the ultimate goal of providing value-enhanced, multi-faceted surgical solutions and outstanding patient care.” GSM continues to make further advancements in engineering and development with the recent growth of its spine products portfolio.

Earlier this year GSM expanded its offerings within several other systems including the AnyPlus® Anterior Cervical Interbody Fusion (ACIF) System, the AnyPlus® Dual Lead Screw System, and an anterior cervical plate solution. GSM is also finalizing the launch of the company’s Chrome Cobalt Rod System for scoliosis application, as well as making upgrades to its AnyPlus® NX Percutaneous Pedicle Screw System to provide for better user experience. In the coming months, GSM looks to launch its advanced, Stand-Alone interbody system and Posterior Cervical application, as well expand distribution partnerships with preferred partners who offer DBM, Allograft and Kyphoplasty.

“We expect that the remainder of this year and 2018 will continue to be strong for GSM as we have a number of products in development,” said Kurt Neesley, U.S. Sales and Business Development Director. Given the company’s expanded suite of product offerings, GSM expects demand for the company’s spinal solutions to increase substantially.

“We are focused on growing our sales team and curating a strong network of distributor partnerships to meet surgeon demand,” Neesley stated. “GSM is committed to providing best-in-class service to our distributors and surgeons to promote better patient outcomes.”

For more information about distributor partnership opportunities, please contact kneesley@gsmedicalusa.com.

Media Relations Contact:
Amanda Collins
182068@email4pr.com I Phone: 949.380.6385 x213
FAX: 866.600.9712
6 Wrigley
Irvine, CA 92618
www.gsmedicalusa.com

SOURCE GS Medical

FARMINGDALE, N.Y., Oct. 25, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today cited data that demonstrated the use of BoneScalpel can produce up to a 40% cost reduction in biologic grafting material spend in spinal fusion procedures.

The data was presented today by Dr. Wade Jensen of the Center for Neurosciences, Orthopaedics & Spine (“CNOS”), at the 32^nd Annual Meeting of the North American Spine Society (“NASS”) in Orlando, Florida. The data showed an average cost savings of $1,066 in bone graft material when the Misonix BoneScalpel was employed compared to the use of standard power drill instruments. The Misonix BoneScalpel ultrasonically cuts bone using a 1mm thick blunt blade. The result is a clean cut that preserves healthy bone which can be used for grafting, and spares the surrounding soft tissue. The study is based on a retrospective analysis including 144 cases, 44 of which were done using the Misonix BoneScalpel. The remaining 100 cases were done with a 3mm rotating matchstick drill bit (“burr”) currently in broad use in surgical suites throughout the U.S. An estimated $1.9 billion is spent annually on bone graft substitutes.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “The data presented today are a strong validation of the efficacy of the BoneScalpel in producing significant cost savings in the surgical suite. This data demonstrates the value of using ultrasonic bone removal over standard electric power instruments both in the precision of the bone removal and the reduction in overall bone destruction. The ability to ultrasonically remove bone in a manner that enhances the ability for successful bone grafting while minimizing the need for biological grafting material represents an important step forward for patients, surgeons and medical institutions. We believe that the BoneScalpel can become the standard of care for precision bone cutting while sparing soft tissue and delivering significant cost savings to the healthcare process.”

Misonix will be exhibiting at NASS 2017 at booth #765 from Wednesday, October 25, 2017 through Saturday, October 28, 2017.

About NASS
The North American Spine Society (“NASS”) is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value- and evidence-based spine care for patients.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact
Misonix Contact:
Joe Dwyer
631-694-9555
invest@misonix.com

Investor Contact
Joe Diaz
Lytham Partners
602-889-9700
info@misonix.com

Warren, NJ, October 26, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today FDA 510(k) clearance and full commercial launch of FIBERGRAFT BG Matrix – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Matrix is the third generation product in the company’s FIBERGRAFT line of bioactive glass fiber based products. FIBERGRAFT BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.

FIBERGRAFT BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseaous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Here are some comments from the early users of FIBERGRAFT BG Matrix:
Dr. Paul Slosar MD of the San Francisco Spine Institute commented, “I have an interest in the growing scientific research focused on bone graft extenders and am impressed by the FiberGraft’s basic science data. I recently had the opportunity to use the Fibergraft Matrix in several cases where I needed to augment my posterior fusion, when we didn’t have enough autograft. The Fibergraft had excellent handling characteristics and interdigitated very nicely with the host bone. The Fibergraft provided me with an excellent option to reinforce my bone graft and, based on their scientific data, I anticipate excellent clinical fusion results.”

Dr. Adam Bruggeman MD of the Texas Spine Care Center commented, “Fibergraft Matrix from Prosidyan is an innovative update to their leading fiber based bioglass portfolio. Matrix is easy to manipulate, allowing for multiple applications. It is now my preferred graft for all biologic applications in the spine.”

Dr. Todd Allen, MD, PhD Associate Professor Orthopaedic Surgery UCSD commented, “The structural and handling features are dynamic and second to none with an innate ability to wrap around bony structures and wick needed blood and cells to the region. The structural and biologic capabilities of this unique synthetic are powerful, and make this a great product for the future of spine surgery, both in open and MIS applications.”

Prosidyan’s Founder & CEO Charanpreet Bagga informed that FIBERGRAFT BG Matrix was presented at the 2017 North American Spine Society Innovative Technology Presentations on October 25th by Dr. William Walsh PhD, of UNSW. There were only seven technologies selected for presentation at this forum and FIBERGRAFT is the only synthetic bone graft substitute selected for this prestigious forum.

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 9,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.

Contact Information

Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com

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